Efficacy of Fish Oil in Lupus Patients

This study has been completed.

Sponsor:

Michelle Petri M.D.,MPH

ClinicalTrials.gov Identifier:

NCT00828178

First Posted: January 23, 2009

Last Update Posted: November 18, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks

Placebo Comparator: corn starch

corn starch; flow-mediated dilation of the brachial artery

Device: flow-mediated dilation of the brachial artery

flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks

Other: corn starch

3 capsules qd for 12weeks

Detailed Description:

Patients with SLE have a fifty-fold increased risk of myocardial infarction. This risk is not totally explained by traditional cardiovascular risk factors. In a previous double-blind study of atorvastatin in SLE, there was no reduction in surrogate measures of coronary artery disease (coronary calcium, coronary IMT, carotid plaque) and no effect on inflammatory markers such as ICAM, VCAM, IL-6 and CRP. We need to find novel approaches to reduce coronary artery disease in SLE. In a preliminary study, omega-3 was shown to improve flow mediated dilation of the brachial artery, oxidative stress and disease activity in lupus patients. In this study we will determine if omega-3 improves brachial artery flow dilation, disease activity and other vascular inflammatory markers (IL-6, s-VCAM-1, s-ICAM-1) in SLE, in a double-blind placebo-controlled trial.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with a clinical diagnosis of SLE are eligible.

Patients must be 18 years of age or older and able to give informed consent.

Exclusion Criteria:

SLE patients who are allergic to fish oil or any omega 3 product.

Patients who are pregnant or are planning to become pregnant or are nursing.

Omega-3 use within the previous 6 weeks of enrollment.

Use of warfarin or heparin.

Patients who have coronary artery disease.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828178